FDA Inspection
Wooil C & Tech Corp.Wooil C & Tech Corp. – FDA Inspection, Sep 1, 2017
Record Details
This FDA Inspection record concerns Wooil C & Tech Corp., with an inspection on September 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7bdb6984-9c0d-41eb-83e3-7958fb78e455
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024046
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.101(b)Identification of new containers
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.194(d)Laboratory equipment calibration records
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